Tulsa-Pro 104495
Tulsa-Pro 104495 is a medical device (FDA Class II; FDA product code PLP, High Intensity Ultrasound System For Prostate Tissue Ablation) made by Profound Medical Inc, cleared under FDA 510(k) K191200 on 15 Aug 2019 and listed in FDA GUDID since 21 Oct 2019 (UDI-DI 07540281000076), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07540281000076 | Date21 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191200 | Date15 Aug 2019 | StatusActive |
Official records
- AccessGUDID record 07540281000076
- FDA 510(k) database K191200
Across registries
- FDA 510(k) K191200 decided 15 Aug 2019 Active
- FDA GUDID UDI-DI 07540281000076 listed 21 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K191200
- Listed FDA GUDID 07540281000076
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tulsa-Pro
- Generic name
- Therapeutic oncological/gynaecological ultrasound system
- Model / reference
- 104495
- Primary DI / UDI-DI
- 07540281000076
- 510(k) Number
- FDA product code
- PLP
- GMDN term
- Therapeutic oncological/gynaecological ultrasound system
- Device class
- Class II
- Regulation number
- 876.4340
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe